Comparative Study of Immediate Single Unit Implants in Early Loading Protocols, With or Without Photobiomodulation.

Dental Implant Clinical Trial

Official title:

Comparative Study of Immediate Single Unit Helix GM - Neodent Implants in Early Loading Protocols, With or Without Acqua Surface and With or Without Low Level Laser Photobiomodulation (LLLT). Single-blind Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05106855
• Other study ID #: RCT-NEO-PBM-21
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2022
• Est. completion date: May 20, 2024

Study information

• Verified date: May 2023
• Source: University of Santiago de Compostela
• Contact: Mário Pérez-Sayáns, PhD
• Phone: 0034626233504
• Email: mario.perez[@]usc.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Post-extraction implants are an alternative to traditional implant placement on completely healed bone, in order to reduce the number of surgical interventions, shorten treatment time, maintain bone architecture and thus provide better aesthetics. This study focuses on evaluating the results obtained by opting for different immediate placement of single dental implants protocols in a fresh alveolus, and its general objective is to compare implant stability and marginal bone loss (MBL) in implants installed post-extraction. For this, the investigators will placement Grand Morse Acqua or NeoPoros implants (Helix GM - Neodent, Curitiba, Brazil), in early loading protocols, with or without low level laser photobiomodulation (LLLT), in patients attending the Master of Oral Medicine, Oral Surgery and Implantology of the University of Santiago de Compostela for oral rehabilitation using osseointegrated single dental implants in the maxillary and/or mandibular region.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 20, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients satisfying all inclusion criteria and none of the exclusion criteria will be informed verbally and in writing about the study and signed the informed consent form.
• The implant area is free of infection
• Patients without systemic pathology or medical and general contraindications that are absolute contraindications for surgical procedures;
• Adults who agree to take part in the study and signed the informed consent form.
• Smokers of less than 5 cigarettes/day.
• Not to be completely edentulous.
• Need for extraction of at least one tooth.
• Post-extraction bone area (fresh alveolus).
• Patients with sufficient bone height to obtain primary stability for implant installation (2 mm longer than the largest root).
• Edentulous areas with sufficient mesial-distal, buccolingual and interocclusal space for the placement of an anatomical restoration with a prosthetic space of at least 5 mm.

Exclusion Criteria:

• Immunosuppressed.
• Smokers of more than 5 cigarettes/day.
• Bleeding rate greater than 30 %.
• Presence of active or uncontrolled periodontal disease;
• Patients with less than 2 mm of keratinised gingiva.
• Implants with primary stability with ISQ < 50
• When this is not possible, assume a security margin to the inferior dental nerve of at least 1 mm.
• Previus history of local radiotherapy in the head and neck region.

Related Conditions & MeSH terms

• Dental Implant
• Tooth Extraction

Intervention

Radiation:
• Low Laser Radiation
One group will receive laser application to check if there is acceleration of healing.

Other:
• Changing the implant surface
Changing the treatment surface of the dental implant to see if osseointegration occurs more quickly.

Radiation:
• Low Laser Radiation off
This group will receive laser application off.

Procedure:
• Implant placement immediately after tooth extraction
When the last alternative is tooth extraction, this will be done, and in the same surgical intervention the dental implant will be placed.
• Installing the dental crown with early loading
The installation of the dental crowns will be performed in a period of 6 to 8 weeks, after the dental implant has been installed.

Locations

Country	Name	City	State
Spain	Universidad de Santiago de Compostela	Santiago De Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
University of Santiago de Compostela

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival rate	After comparative of; Acqua/NeoPoros surface and LLLT/No LLLT application. Final total number.	3 months
Primary	Implant stability	Basal and 3 months postimplantation measured by Implant Stability Quotient (ISQ).	3 months
Primary	Marginal bone loss	Measured (mm) from the implant platform to the most coronal part of the peri-implant bone crest.	3 months
Secondary	Implant failure	To be assessed 3 months after surgery. Implant failure will be defined as implant failure when it is necessary to remove the implant due to implant mobility as a consequence of loss of osseointegration. Final total number.	3 months